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Juvederm Volbella Xc Generic Name & Formulations
Legal Class
PP
General Description
Hyaluronic acid 15mg/mL, 0.3% w/w lidocaine; injectable gel implant.
Pharmacological Class
Dermal filler.
How Supplied
Single-use syringe—1 (w. needles)
Manufacturer
Generic Availability
NO
Juvederm Volbella Xc Indications
Indications
Lip augmentation. Correction of perioral rhytids.
Juvederm Volbella Xc Dosage and Administration
Adult
See full labeling. Inject slowly with least amount of pressure necessary. Wait 3 secs after injecting first small amount before proceeding with rest of the inj. May use supplementary anesthesia during and post-inj. >21yrs: Individualize. Initial treatment: usually 2.6mL; max 6mL per inj; repeat treatment: usually 1.6mL. Max limit: 20mL/60kg per year. May require touch-up treatments to achieve desired effect.
Children
Not established.
Juvederm Volbella Xc Contraindications
Contraindications
History of anaphylaxis or presence of multiple severe allergies. Allergies to Gram (+) bacterial proteins, lidocaine.
Juvederm Volbella Xc Boxed Warnings
Not Applicable
Juvederm Volbella Xc Warnings/Precautions
Warnings/Precautions
Should only be used by trained and experienced healthcare practitioners. Obtain patient's complete medical history prior to initiation. Avoid intravascular inj; discontinue immediately if changes in vision, signs of stroke, blanching of skin or unusual pain during or shortly after procedure occurs. Risk of infection. Defer if active inflammatory process or infection is present at specific sites. Use in non-lip or non-perioral areas: not established. Possible risk of an inflammatory reaction at implant site if laser treatment, chemical peeling, or any other procedure based on active dermal response is considered after Juvederm Volbella XC or if product is given before skin has healed completely after such a procedure. Known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders: not studied. Advise patients to avoid strenuous exercise, extensive sun or heat, and alcoholic beverages within first 24hrs. Patients (<22yrs), pregnancy, nursing mothers: not established.
Juvederm Volbella Xc Pharmacokinetics
See Literature
Juvederm Volbella Xc Interactions
Interactions
Caution with concomitant immunosuppressants. Increased bruising or bleeding at inj sites with concomitant aspirin, NSAIDs, warfarin.
Juvederm Volbella Xc Adverse Reactions
Adverse Reactions
Inj site reactions (eg, swelling, tenderness, firmness, bruising, lumps/bumps, redness, pain, discoloration, itching, dryness); rare: vision impairment, blindness, cerebral ischemia/hemorrhage, stroke, skin necrosis, facial structure damage.
Juvederm Volbella Xc Clinical Trials
See Literature
Juvederm Volbella Xc Note
Not Applicable
Juvederm Volbella Xc Patient Counseling
See Literature
